Fast Facts:
- The FDA is alerting tattoo artists and consumers that they
should not use tattoo inks marketed and distributed by A Thousand
Virgins, in grey wash shades labeled G1, G2, and G3 (Lot #129 exp
1/16).
- Through testing, the agency has found bacterial contamination, including Mycobacterium chelonae,
in unopened bottles of these tattoo inks. The FDA tested the inks
to assist the Florida Department of Health in its investigation of an
outbreak of mycobacterial infections in people who recently got
tattoos.
- On August 4, 2015, A Thousand Virgins recalled
certain tattoo inks sold separately and in sets, but the FDA is
concerned that artists and consumers are continuing to use these
contaminated inks from their current stock. Also, tattoo products with
the same lot number manufactured by A Thousand Virgins may still
be available online and may be marketed by other distributors. The
inks were sold in single units and in sets.
- Artists who purchase tattoo inks and consumers who
purchase tattoo inks or who seek tattooing should check the ink
bottles to see if they are included in the recall. If you find inks
subject to recall, place the closed bottles of ink into a plastic bag,
sealing or tying off the bag to prevent leakage. Put this first
bag into a second bag and tie off this bag separately. Check with
your local waste management authorities for any disposal
requirements in effect in your area.
What is the Problem?
FDA has identified microbiological contamination in unopened tattoo
inks made by A Thousand Virgins, Inc. The tattoo inks are labeled G1,
G2, and G3, indicating the shade.
FDA has tested unopened bottles of these inks and found contamination with a human pathogen, Mycobacterium chelonae, as well as Microbacterium organisms, and the molds Cryptococcus albidus and members of the Penicillium genus.
FDA is warning tattoo ink manufacturers, tattoo artists and
consumers not to use these tattoo inks that are contaminated or have
been recalled.
What are the Symptoms of Illness/Injury?
When tattoo ink contaminated with mycobacteria is injected
into the skin, the bacteria can cause an infection that remains at the
site or that may spread throughout the body. Such infection might
result in redness; swelling; itching; raised pink, red, or purple
blemishes in the tattoo; or pain in the tattoo that does not go away.
If you have these symptoms, you should seek medical treatment. You may
also notice swollen and tender lymph nodes, at sites local and distant
to the infected tattoo.
These infections can be severe and may require extensive treatment
with antibiotics, hospitalization, or surgery. Sepsis, a potentially
life-threatening body-wide infection of the blood, has been reported in
cases of injection of contaminated tattoo inks. Once the infection has
healed, the area may remain permanently scarred.
Who is at Risk?
Because tattooing involves injecting ink under the skin, the use of
contaminated inks may lead to an infection. People with pre-existing
medical conditions, including heart or circulatory disease, diabetes,
or patients with compromised immune systems, are particularly
vulnerable.
What Do Consumers and Tattoo Artists Need To Do?
Consumers and tattoo artists should know where their materials come
from and should be able to identify and remove the contaminated inks
described above. If you have used these inks and adverse events occur,
contact the manufacturer and the FDA. Tattoo artists should not dilute
inks with tap water, distilled water, filtered water, reverse osmosis
water, or other non-sterile water that has the potential to be
contaminated. In addition, consumers and tattoo artists should purchase
inks from reputable manufacturers who source their ink ingredients
appropriately and can attest to using good manufacturing practices. If
you are a tattoo artist and are applying body art, advise your clients
to monitor the application site closely and seek medical care if they
notice redness, swelling, itching, bumps, or blemishes, or have pain in
the tattoo site that does not go away. Please also inform your clients
that they should be alert for rashes and inflamed tattooed areas
beyond the normal healing period, as well as any tender lymph nodes,
even those that are not near the tattoo. Please ask your clients to
contact you, the artist, if they experience any of these symptoms, so
you may remove the potentially contaminated ink from use. They should
also seek medical care for their symptoms.
People with infected tattoos and tattoo artists whose clients notify
them of potentially infected tattoos can report adverse events or side
effects through the MedWatch Safety Information and Adverse Event Reporting Program.
What Do the Contaminated Products Look Like?
The front panel of the label bears a circular logo with the name of
the manufacturer, “A Thousand Virgins.” Centered within the circle are
G1, G2, or G3, indicating the particular shade of grey wash ink.
Bottles are marked as Lot #129 with an expiration date of 1/16. The
contaminated inks are sold singly and in sets of three or four bottles.
Where are they Distributed?
The tattoo inks and tattoo kits are sold online by A Thousand Virgins, at tattoo conventions and through other websites.
What is FDA doing about the Problem?
The FDA is working with A Thousand Virgins to recall the
contaminated inks and is investigating to determine how they became
contaminated. The FDA and the Florida Department of Health will provide
more information as it becomes available.
How can I Report a Problem?
Adverse events (bad reactions) related to the use of FDA-regulated
products can be reported through the MedWatch Safety Information and
Adverse Event Reporting Program by:
For More Information:
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm457439.htm
Labels: bacterial contamination, FDA Alert, Tattoo ink recall